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Abstract:

A method of directing energy to tissue includes the initial step of
positioning an energy applicator for delivery of energy to tissue. The
energy applicator is operably associated with an electrosurgical power
generating source. The method includes the steps of determining one or
more operating parameters associated with the electrosurgical power
generating source based on specific absorption rate data associated with
the energy applicator, and transmitting energy from the electrosurgical
power generating source through the energy applicator to tissue.

Claims:

1. A method of directing energy to tissue, comprising the steps of;
positioning an energy applicator for delivery of energy to tissue, the
energy applicator operably associated with an electrosurgical power
generating source; determining at least one operating parameter
associated with the electrosurgical power generating source based on
specific absorption rate data associated with the energy applicator; and
transmitting energy from the electrosurgical power generating source
through the energy applicator to tissue.

2. The method of directing energy to tissue in accordance with claim 1,
wherein the specific absorption rate data associated with the energy
applicator is based on a positional transition of at least one boundary
of a color band selected from time-series image data associated with the
energy applicator.

3. The method of directing energy to tissue in accordance with claim 1,
wherein the at least one operating parameter associated with the
electrosurgical power generating source is selected from the group
consisting of temperature, impedance, power, current, voltage, mode of
operation, and duration of application of electromagnetic energy.

4. The method of directing energy to tissue in accordance with claim 1,
wherein the specific absorption rate data associated with the energy
applicator is based on analysis of time-series image data associated with
the energy applicator.

5. The method of directing energy to tissue in accordance with claim 4,
wherein analysis of the time-series image data associated with the energy
applicator includes the steps of: selecting a color band of the
time-series image data; thresholding the time-series image data to detect
at least one boundary of the selected color band in each image data of
the thresholded time-series image data; determining a change in
temperature as a function of positional transition of the at least one
boundary of each image data of the thresholded time-series image data;
and calculating a specific absorption rate around the energy applicator
as a function of the determined change in temperature.

6. The method of directing energy to tissue in accordance with claim 5,
wherein selecting the color band of the time-series image data includes
the step of outputting at least one image data of the time-series image
data to a display device.

7. The method of directing energy to tissue in accordance with claim 6,
wherein selecting the color band of the time-series image data further
includes the step of providing a pointing device to enable user selection
of the color band.

8. The method of directing energy to tissue in accordance with claim 5,
wherein the at least one boundary of the selected color band is an inner
boundary of the selected color band.

9. The method of directing energy to tissue in accordance with claim 5,
wherein the at least one boundary of the selected color band is an outer
boundary of the selected color band.

10. The method of directing energy to tissue in accordance with claim 5,
wherein calculating the specific absorption rate around the energy
applicator as a function of the determined change in temperature includes
obtaining a frame rate of an image acquisition device associated with the
time-series image data.

11. A method of directing energy to tissue, comprising the steps of:
positioning an energy applicator for delivery of energy to a target
tissue volume, the energy applicator operably associated with an
electrosurgical power generating source; determining at least one
operating parameter associated with the electrosurgical power generating
source based on specific absorption rate data associated with the energy
applicator; and transmitting energy from the electrosurgical power
generating source through the energy applicator to the target tissue
volume; acquiring image data including tissue temperature information of
the target tissue volume by imaging the target tissue volume using at
least one imaging modality; calculating a specific absorption rate as a
function of the tissue temperature information from the image data; and
determining at least one operating parameter associated with the
electrosurgical power generating source based on the calculated specific
absorption rate.

12. The method of directing energy to tissue in accordance with claim 11,
wherein determining at least one operating parameter associated with the
electrosurgical power generating source based on specific absorption rate
data associated with the energy applicator includes retrieving thermal
profile data from a picture archiving and communication system (PACS).

13. The method of directing energy to tissue in accordance with claim 11,
wherein calculating a specific absorption rate as a function of the
tissue temperature information from the image data allows detection of a
beginning of a non-uniform ablation field.

14. The method of directing energy to tissue in accordance with claim 11,
wherein the at least one operating parameter associated with the
electrosurgical power generating source is selected from the group
consisting of temperature, impedance, power, current, voltage, mode of
operation, and duration of application of electromagnetic energy.

15. The method of directing energy to tissue in accordance with claim 11,
further comprising the step of: adjusting a position of the energy
applicator based on the calculated specific absorption rate.

16. The method of directing energy to tissue in accordance with claim 15,
wherein the position of the energy applicator is adjusted by rotating the
energy applicator about a longitudinal axis thereof.

17. The method of directing energy to tissue in accordance with claim 16,
wherein the energy applicator is configured to emit a directional
radiation pattern that rotates therewith during rotation of the energy
applicator about the longitudinal axis thereof.

Description:

BACKGROUND

[0001] 1. Technical Field

[0002] The present disclosure relates to a system and method for measuring
the specific absorption rate of electromagnetic energy emitted by
energy-delivery devices, such as energy-emitting probes or electrodes,
and, more particularly, to specific absorption rate measurement and
characterization of energy-delivery devices using a thermal phantom and
image analysis.

[0003] 2. Discussion of Related Art

[0004] Treatment of certain diseases requires the destruction of malignant
tissue growths, e.g., tumors. Electromagnetic radiation can be used to
heat and destroy tumor cells. Treatment may involve inserting ablation
probes into tissues where cancerous tumors have been identified. Once the
probes are positioned, electromagnetic energy is passed through the
probes into surrounding tissue.

[0005] In the treatment of diseases such as cancer, certain types of tumor
cells have been found to denature at elevated temperatures that are
slightly lower than temperatures normally injurious to healthy cells.
Known treatment methods, such as hyperthermia therapy, heat diseased
cells to temperatures above 41° C. while maintaining adjacent
healthy cells below the temperature at which irreversible cell
destruction occurs. These methods involve applying electromagnetic
radiation to heat, ablate and/or coagulate tissue. Microwave energy is
sometimes utilized to perform these methods. Other procedures utilizing
electromagnetic radiation to heat tissue also include coagulation,
cutting and/or ablation of tissue. Many procedures and types of devices
utilizing electromagnetic radiation to heat tissue have been developed.

[0006] In treatment methods utilizing electromagnetic radiation, such as
hyperthermia therapy, the transference or dispersion of heat generally
may occur by mechanisms of radiation, conduction, and convection.
Biological effects that result from heating of tissue by electromagnetic
energy are often referred to as "thermal" effects. "Thermal radiation"
and "radiative heat transfer" are two terms used to describe the transfer
of energy in the form of electromagnetic waves (e.g., as predicted by
electromagnetic wave theory) or photons (e.g., as predicted by quantum
mechanics). In the context of heat transfer, the term "conduction"
generally refers to the transfer of energy from more energetic to less
energetic particles of substances due to interactions between the
particles. The term "convection" generally refers to the energy transfer
between a solid surface and an adjacent moving fluid. Convection heat
transfer may be a combination of diffusion or molecular motion within the
fluid and the bulk or macroscopic motion of the fluid.

[0007] The extent of tissue heating may depend on several factors
including the rate at which energy is absorbed by, or dissipated in, the
tissue under treatment. The electromagnetic-energy absorption rate in
biological tissue may be quantified by the specific absorption rate
(SAR), a measure of the energy per unit mass absorbed by tissue and is
usually expressed in units of watts per kilogram (W/kg). For SAR
evaluation, a simulated biological tissue or "phantom" having physical
properties, e.g., dielectric constant, similar to that of the human body
is generally used.

[0008] One method to determine the SAR is to measure the rate of
temperature rise in tissue as a function of the specific heat capacity
(often shortened to "specific heat") of the tissue. This method requires
knowledge of the specific heat of the tissue. A second method is to
determine the SAR by measuring the electric field strength in tissue.
This method requires knowledge of the conductivity and density values of
the tissue.

[0009] The relationship between radiation and SAR may be expressed as

S A R = 1 2 σ ρ E 2 ,
( 1 ) ##EQU00001##

where σ is the tissue electrical conductivity in units of Siemens
per meter (S/m), ρ is the tissue density in units of kilograms per
cubic meter (kg/m3), and |E| is the magnitude of the local electric
field in units of volts per meter (V/m).

[0010] The relationship between the initial temperature rise ΔT
(° C.) in tissue and the specific absorption rate may be expressed
as

Δ T = 1 c S A R Δ
t , ( 2 ) ##EQU00002##

where c is the specific heat of the tissue (or phantom material) in units
of Joules/kg-° C., and Δt is the time period of exposure in
seconds. Substituting equation (1) into equation (2) yields a relation
between the induced temperature rise in tissue and the applied electric
field as

Δ T = 1 2 σ ρ c E 2
Δ t . ( 3 ) ##EQU00003##

[0011] As can be seen from the above equations, modifying the local
electric-field amplitude directly affects the local energy absorption and
induced temperature rise in tissue. In treatment methods such as
hyperthermia therapy, it would be desirable to deposit an electric field
of sufficient magnitude to heat malignant tissue to temperatures above
41° C. while limiting the SAR magnitude in nearby healthy tissue
to be less than that within the tumor to keep the healthy cells below the
temperature causing cell death.

[0012] SAR measurement and the characterization of energy-delivery devices
may ensure clinical safety and performance of the energy-delivery
devices. SAR measurement and characterization of energy-delivery devices
may generate data to facilitate planning and effective execution of
therapeutic hyperthermic treatments.

SUMMARY

[0013] The present disclosure relates to a method of directing energy to
tissue including the initial step of positioning an energy applicator for
delivery of energy to tissue. The energy applicator is operably
associated with an electrosurgical power generating source. The method
includes the steps of determining one or more operating parameters
associated with the electrosurgical power generating source based on
specific absorption rate data associated with the energy applicator, and
transmitting energy from the electrosurgical power generating source
through the energy applicator to tissue.

[0014] The present disclosure also relates to a method of directing energy
to a target tissue volume including the initial step of positioning an
energy applicator for delivery of energy to tissue. The energy applicator
is operably associated with an electrosurgical power generating source.
The method includes the steps of determining one or more operating
parameters associated with the electrosurgical power generating source
based on specific absorption rate data associated with the energy
applicator, and transmitting energy from the electrosurgical power
generating source through the energy applicator to the target tissue
volume. The method also includes the steps of acquiring image data
including tissue temperature information of the target tissue volume by
imaging the target tissue volume using one or more imaging modalities,
calculating a specific absorption rate as a function of the tissue
temperature information from the image data, and determining one or more
operating parameters associated with the electrosurgical power generating
source based on the calculated specific absorption rate.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Objects and features of the presently disclosed system and method
for specific absorption rate measurement and characterization of
energy-delivery devices and the presently disclosed electrosurgical
system and methods for directing energy to tissue in accordance with
specific absorption rate data associated with an energy applicator will
become apparent to those of ordinary skill in the art when descriptions
of various embodiments thereof are read with reference to the
accompanying drawings, of which:

[0016]FIG. 1 is a schematic illustration of a thermal profiling system
including an energy applicator array positioned for the delivery of
energy to a targeted tissue area according to an embodiment of the
present disclosure;

[0017]FIG. 2 is a perspective view, partially broken-away, of an
embodiment of a test fixture assembly in accordance with the present
disclosure;

[0018] FIG. 3 is an exploded, perspective view, partially broken-away, of
the test fixture assembly of FIG. 2 shown with a thermally-sensitive
medium according to an embodiment of the present disclosure;

[0019]FIG. 4 is a perspective view, partially broken-away, of test
fixture assembly of FIGS. 2 and 3 according to an embodiment of the
present disclosure shown with an energy applicator associated therewith;

[0020]FIG. 5 is a cross-sectional view of an embodiment of a
thermally-sensitive medium including a cut-out portion in accordance with
the present disclosure;

[0021]FIG. 6 is a perspective view of a support member of the test
fixture assembly of FIGS. 2 through 4 according to an embodiment of the
present disclosure shown with a portion of the thermally-sensitive medium
of FIG. 5 associated therewith;

[0022] FIGS. 7 and 8 are partial, enlarged views schematically
illustrating the thermally-sensitive medium of FIG. 5 and the energy
applicator of FIG. 4 centrally aligned with the longitudinal axis of the
thermally-sensitive medium's cut-out portion according to an embodiment
of the present disclosure;

[0023]FIG. 9 is a schematic, longitudinal cross-sectional view of an
embodiment of a thermal profiling system including the test fixture
assembly of FIGS. 2 through 4 and the energy applicator and the
thermally-sensitive medium of FIGS. 7 and 8 in accordance with the
present disclosure;

[0024]FIG. 10 is a schematic diagram illustrating the thermally-sensitive
medium of the thermal profiling system of FIG. 9 during operation
according to an embodiment of the present disclosure shown with a
schematically-illustrated representation of a thermal radiation pattern
formed on the thermally-sensitive medium at time t equal to t1;

[0025]FIG. 11 is a schematic diagram illustrating a thresholded pattern
image of a portion of the thermally-sensitive medium of FIG. 10 showing a
selected temperature band at time t equal to t1 according to an
embodiment of the present disclosure;

[0026]FIG. 12 is a schematic diagram illustrating the thermally-sensitive
medium of the thermal profiling system of FIG. 9 during operation
according to an embodiment of the present disclosure shown with a
schematically-illustrated representation of a thermal radiation pattern
formed on the thermally-sensitive medium at time t equal to t2;

[0027]FIG. 13 is a schematic diagram illustrating a thresholded pattern
image of a portion of the thermally-sensitive medium of FIG. 12 showing a
selected temperature band captured at time t equal to t2 according
to an embodiment of the present disclosure;

[0028] FIG. 14 is a schematic diagram illustrating the thermally-sensitive
medium of the thermal profiling system of FIG. 9 during operation
according to an embodiment of the present disclosure shown with a
schematically-illustrated representation of a thermal radiation pattern
formed on the thermally-sensitive medium at time t equal to t3;

[0029] FIG. 15 is a schematic diagram illustrating a thresholded pattern
image of a portion of the thermally-sensitive medium of FIG. 14 showing a
selected temperature band at time t equal to t3 according to an
embodiment of the present disclosure;

[0030] FIG. 16A is a schematic diagram illustrating a thresholded pattern
image of a thermally-sensitive medium according to an embodiment of the
present disclosure showing a selected temperature band at time t equal to
tn;

[0031] FIG. 16B is a schematic view of the thresholded pattern image of
FIG. 16A shown with contour lines at the inner and outer boundaries of
the temperature band;

[0032] FIG. 17A is a schematic diagram illustrating a thresholded pattern
image of a thermally-sensitive medium according to an embodiment of the
present disclosure showing a selected temperature band at time t equal to
t+1;

[0033] FIG. 17B is a schematic view of the thresholded pattern image of
FIG. 17A shown with contour lines connecting a set of points at the inner
and outer boundaries of the temperature band;

[0034] FIGS. 18 and 19 are schematic diagrams illustrating the positional
relationship between points lying on the boundary lines of the
temperature band of FIGS. 16B and 17B according to an embodiment of the
present disclosure;

[0035] FIG. 20 is a diagrammatic representation of a simulated radiation
pattern for an energy applicator according to an embodiment of the
present disclosure;

[0036] FIG. 21 is a diagrammatic representation of a simulated radiation
pattern for an energy applicator according to another embodiment of the
present disclosure;

[0037] FIG. 22 is a flowchart illustrating a method of directing energy to
tissue according to an embodiment of the present disclosure;

[0038]FIG. 23 is a flowchart illustrating a sequence of method steps for
performing the step 2220 of the method illustrated in FIG. 22 according
to an embodiment of the present disclosure; and

[0039]FIG. 24 is a flowchart illustrating a method of directing energy to
tissue according to another embodiment of the present disclosure.

DETAILED DESCRIPTION

[0040] Hereinafter, embodiments of the system and method for specific
absorption rate (SAR) measurement and characterization of energy-delivery
devices of the present disclosure and embodiments of the presently
disclosed electrosurgical system and methods for directing energy to
tissue in accordance with SAR data associated with an energy applicator
are described with reference to the accompanying drawings. Like reference
numerals may refer to similar or identical elements throughout the
description of the figures. As shown in the drawings and as used in this
description, and as is traditional when referring to relative positioning
on an object, the term "proximal" refers to that portion of the
apparatus, or component thereof, closer to the user and the term "distal"
refers to that portion of the apparatus, or component thereof, farther
from the user.

[0041] This description may use the phrases "in an embodiment," "in
embodiments," "in some embodiments," or "in other embodiments," which may
each refer to one or more of the same or different embodiments in
accordance with the present disclosure. For the purposes of this
description, a phrase in the form "A/B" means A or B. For the purposes of
the description, a phrase in the form "A and/or B" means "(A), (B), or (A
and B)". For the purposes of this description, a phrase in the form "at
least one of A, B, or C" means "(A), (B), (C), (A and B), (A and C), (B
and C), or (A, B and C)".

[0042] Electromagnetic energy is generally classified by increasing energy
or decreasing wavelength into radio waves, microwaves, infrared, visible
light, ultraviolet, X-rays and gamma-rays. As it is used in this
description, "microwave" generally refers to electromagnetic waves in the
frequency range of 300 megahertz (MHz) (3×108 cycles/second)
to 300 gigahertz (GHz) (3×1011 cycles/second). As it is used
in this description, "ablation procedure" generally refers to any
ablation procedure, such as microwave ablation, radio frequency (RF)
ablation or microwave ablation assisted resection. As it is used in this
description, "energy applicator" generally refers to any device that can
be used to transfer energy from a power generating source, such as a
microwave or RF electrosurgical generator, to tissue. As it is used in
this description, "transmission line" generally refers to any
transmission medium that can be used for the propagation of signals from
one point to another.

[0043] As it is used in this description, "length" may refer to electrical
length or physical length. In general, electrical length is an expression
of the length of a transmission medium in terms of the wavelength of a
signal propagating within the medium. Electrical length is normally
expressed in terms of wavelength, radians or degrees. For example,
electrical length may be expressed as a multiple or sub-multiple of the
wavelength of an electromagnetic wave or electrical signal propagating
within a transmission medium. The wavelength may be expressed in radians
or in artificial units of angular measure, such as degrees. The electric
length of a transmission medium may be expressed as its physical length
multiplied by the ratio of (a) the propagation time of an electrical or
electromagnetic signal through the medium to (b) the propagation time of
an electromagnetic wave in free space over a distance equal to the
physical length of the medium. The electrical length is in general
different from the physical length. By the addition of an appropriate
reactive element (capacitive or inductive), the electrical length may be
made significantly shorter or longer than the physical length.

[0044] As used in this description, the term "real-time" means generally
with no observable latency between data processing and display. As used
in this description, "near real-time" generally refers to a relatively
short time span between the time of data acquisition and display.

[0045] Various embodiments of the present disclosure provide systems and
methods of directing energy to tissue in accordance with specific
absorption rate data associated with an energy applicator. Embodiments
may be implemented using electromagnetic radiation at microwave
frequencies or at other frequencies. An electromagnetic energy delivery
device including an energy applicator array, according to various
embodiments, is designed and configured to operate between about 300 MHz
and about 10 GHz.

[0046] Various embodiments of the presently disclosed electrosurgical
system including an energy applicator, or energy applicator array, are
suitable for microwave ablation and for use to pre-coagulate tissue for
microwave ablation assisted surgical resection. In addition, although the
following description describes the use of a dipole microwave antenna,
the teachings of the present disclosure may also apply to a monopole,
helical, or other suitable type of microwave antenna (or RF electrodes).

[0047] An electrosurgical system 100 according to an embodiment of the
present disclosure is shown in FIG. 1 and includes an electromagnetic
energy delivery device or energy applicator array "E". Energy applicator
array "E" may include one or more energy applicators or probes. Probe
thickness may be minimized, e.g., to reduce trauma to the surgical site
and facilitate accurate probe placement to allow surgeons to treat target
tissue with minimal damage to surrounding healthy tissue. In some
embodiments, the energy applicator array "E" includes a plurality of
probes. The probes may have similar or different diameters, may extend to
equal or different lengths, and may have a distal end with a tapered tip.
In some embodiments, the one or more probes may be provided with a
coolant chamber. The probe(s) may be integrally associated with a hub
(e.g., hub 34 shown in FIG. 1) that provides electrical and/or coolant
connections to the probe(s). Additionally, or alternatively, the probe(s)
may include coolant inflow and outflow ports to facilitate the flow of
coolant into, and out of, the coolant chamber. Examples of coolant
chamber and coolant inflow and outflow port embodiments are disclosed in
commonly assigned U.S. patent application Ser. No. 12/401,268 filed on
Mar. 10, 2009, entitled "COOLED DIELECTRICALLY BUFFERED MICROWAVE DIPOLE
ANTENNA", and U.S. Pat. No. 7,311,703, entitled "DEVICES AND METHODS FOR
COOLING MICROWAVE ANTENNAS".

[0048] In the embodiment shown in FIG. 1, the energy applicator array "E"
includes three probes 1, 2 and 3 having different lengths and arranged
substantially parallel to each other. Probes 1, 2 and 3 generally include
a radiating section "R1", "R2" and "R3", respectively, operably connected
by a feedline (or shaft) 1a, 2a and 3a, respectively, to an
electrosurgical power generating source 16, e.g., a microwave or RF
electrosurgical generator. Transmission lines 10, 11 and 12 may be
provided to electrically couple the feedlines 1a, 2a and 3a,
respectively, to the electrosurgical power generating source 16. Located
at the distal end of each probe 1, 2 and 3 is a tip portion 1b, 2b and
3b, respectively, which may be configured to be inserted into an organ
"OR" of a human body or any other body tissue. Tip portion 1b, 2b and 3b
may terminate in a sharp tip to allow for insertion into tissue with
minimal resistance. Tip portion 1b, 2b and 3b may include other shapes,
such as, for example, a tip that is rounded, flat, square, hexagonal, or
cylindroconical. The shape, size and number of probes of the energy
applicator array "E" may be varied from the configuration depicted in
FIG. 1.

[0049] Electrosurgical system 100 according to embodiments of the present
disclosure includes a user interface 50 may include a display device 21,
such as without limitation a flat panel graphic LCD (liquid crystal
display), adapted to visually display one or more user interface elements
(e.g., 23, 24 and 25 shown in FIG. 1). In an embodiment, the display
device 21 includes touchscreen capability, e.g., the ability to receive
user input through direct physical interaction with the display device
21, e.g., by contacting the display panel of the display device 21 with a
stylus or fingertip. A user interface element (e.g., 23, 24 and/or 25
shown in FIG. 1) may have a corresponding active region, such that, by
touching the display panel within the active region associated with the
user interface element, an input associated with the user interface
element is received by the user interface 50.

[0050] User interface 50 may additionally, or alternatively, include one
or more controls 22 that may include without limitation a switch (e.g.,
pushbutton switch, toggle switch, slide switch) and/or a continuous
actuator (e.g., rotary or linear potentiometer, rotary or linear
encoder). In an embodiment, a control 22 has a dedicated function, e.g.,
display contrast, power on/off, and the like. Control 22 may also have a
function that may vary in accordance with an operational mode of the
electrosurgical system 100. A user interface element (e.g., 23 shown in
FIG. 1) may be provided to indicate the function of the control 22.
Control 22 may also include an indicator, such as an illuminated
indicator, e.g., a single- or variably-colored LED (light emitting diode)
indicator.

[0051] In some embodiments, the electrosurgical power generating source 16
is configured to provide microwave energy at an operational frequency
from about 300 MHz to about 2500 MHz. In other embodiments, the power
generating source 16 is configured to provide microwave energy at an
operational frequency from about 300 MHz to about 10 GHz. Power
generating source 16 may be configured to provide various frequencies of
electromagnetic energy.

[0052] Feedlines 1a, 2a and 3a may be formed from a suitable flexible,
semi-rigid or rigid microwave conductive cable, and may connect directly
to an electrosurgical power generating source 16. Feedlines 1a, 2a and 3a
may have a variable length from a proximal end of the radiating sections
"R1", "R2" and "R3", respectively, to a distal end of the transmission
lines 10, 11 and 12, respectively, ranging from a length of about one
inch to about twelve inches. Feedlines 1a, 2a and 3a may be made of
stainless steel, which generally offers the strength required to puncture
tissue and/or skin, Feedlines 1a, 2a and 3a may include an inner
conductor, a dielectric material coaxially surrounding the inner
conductor, and an outer conductor coaxially surrounding the dielectric
material. Radiating sections "R1", "R2" and "R3" may be formed from a
portion of the inner conductor that extends distal of the feedlines 1a,
2a and 3a, respectively, into the radiating sections "R1", "R2" and "R3",
respectively. Feedlines 1a, 2a and 3a may be cooled by fluid, e.g.,
saline, water or other suitable coolant fluid, to improve power handling,
and may include a stainless steel catheter. Transmission lines 10, 11 and
12 may additionally, or alternatively, provide a conduit (not shown)
configured to provide coolant fluid from a coolant source 32 to the
energy applicator array "E".

[0053] As shown in FIG. 1, the electrosurgical system 100 may include a
reference electrode 19 (also referred to herein as a "return" electrode).
Return electrode 19 may be electrically coupled via a transmission line
20 to the power generating source 16. During a procedure, the return
electrode 19 may be positioned in contact with the skin of the patient or
a surface of the organ "OR". When the surgeon activates the energy
applicator array "E", the return electrode 19 and the transmission line
20 may serve as a return current path for the current flowing from the
power generating source 16 through the probes 1, 2 and 3.

[0054] During microwave ablation, e.g., using the electrosurgical system
100, the energy applicator array "E" is inserted into or placed adjacent
to tissue and microwave energy is supplied thereto. Ultrasound or
computed tomography (CT) guidance may be used to accurately guide the
energy applicator array "E" into the area of tissue to be treated. Probes
1, 2 and 3 may be placed percutaneously or surgically, e.g., using
conventional surgical techniques by surgical staff. A clinician may
pre-determine the length of time that microwave energy is to be applied.
Application duration may depend on a variety of factors such as energy
applicator design, number of energy applicators used simultaneously,
tumor size and location, and whether the tumor was a secondary or primary
cancer. The duration of microwave energy application using the energy
applicator array "E" may depend on the progress of the heat distribution
within the tissue area that is to be destroyed and/or the surrounding
tissue.

[0055]FIG. 1 shows a targeted region including ablation targeted tissue
represented in sectional view by the solid line "T". It may be desirable
to ablate the targeted region "T" by fully engulfing the targeted region
"T" in a volume of lethal heat elevation. Targeted region "T" may be, for
example, a tumor that has been detected by a medical imaging system 30.

[0056] Medical imaging system 30, according to various embodiments,
includes a scanner (e.g., 15 shown in FIG. 1) of any suitable imaging
modality, or other image acquisition device capable of generating input
pixel data representative of an image, e.g., a digital camera or digital
video recorder. Medical imaging system 30 may additionally, or
alternatively, include a medical imager operable to form a visible
representation of the image based on the input pixel data. Medical
imaging system 30 may include a storage device such as an internal memory
unit, which may include an internal memory card and removable memory. In
some embodiments, the medical imaging system 30 may be a multi-modal
imaging system capable of scanning using different modalities. Examples
of imaging modalities that may be suitably and selectively used include
X-ray systems, ultrasound (UT) systems, magnetic resonance imaging (MRI)
systems, computed tomography (CT) systems, single photon emission
computed tomography (SPECT), and positron emission tomography (PET)
systems. Medical imaging system 30, according to embodiments of the
present disclosure, may include any device capable of generating digital
data representing an anatomical region of interest. Medical imaging
system 30 may be a multi-modal imaging system capable of scanning tissue
in a first modality to obtain first modality data and a second modality
to obtain second modality data, wherein the first modality data and/or
the second modality data includes tissue temperature information. The
tissue temperature information acquired by the one or more imaging
modalities may be determined by any suitable method, e.g., calculated
from density changes within the tissue.

[0057] Image data representative of one or more images may be communicated
between the medical imaging system 30 and a processor unit 26. Medical
imaging system 30 and the processor unit 26 may utilize wired
communication and/or wireless communication. Processor unit 26 may
include any type of computing device, computational circuit, or any type
of processor or processing circuit capable of executing a series of
instructions that are stored in a memory (not shown) associated with the
processor unit 26. Processor unit 26 may be adapted to run an operating
system platform and application programs. Processor unit 26 may receive
user inputs from a keyboard (not shown), a pointing device 27, e.g., a
mouse, joystick or trackball, and/or other device, communicatively
coupled to the processor unit 26.

[0058] A scanner (e.g., 15 shown in FIG. 1) of any suitable imaging
modality may additionally, or alternatively, be disposed in contact with
the organ "OR" to provide image data. As an illustrative example, the two
dashed lines 15A in FIG. 1 bound a region for examination by the scanner
15, e.g., a real-time ultrasonic scanner.

[0059] In FIG. 1, the dashed line 8 surrounding the targeted region "T"
represents the ablation isotherm in a sectional view through the organ
"OR". Such an ablation isotherm may be that of the surface achieving
possible temperatures of approximately 50° C. or greater. The
shape and size of the ablation isotherm volume, as illustrated by the
dashed line 8, may be influenced by a variety of factors including the
configuration of the energy applicator array "E", the geometry of the
radiating sections "R1", "R2" and "R3", cooling of the probes 1, 2 and 3,
ablation time and wattage, and tissue characteristics. Processor unit 26
may be connected to one or more display devices (e.g., 21 shown in FIG.
1) for displaying output from the processor unit 26, which may be used by
the clinician to visualize the targeted region "T" and/or the ablation
isotherm volume 8 in real-time or near real-time during a procedure,
e.g., an ablation procedure.

[0060] In embodiments, real-time data and/or near real-time data acquired
from CT scan, ultrasound, or MRI (or other scanning modality) that
includes tissue temperature information may be outputted from the
processor unit 26 to one or more display devices. Processor unit 26 is
adapted to analyze image data including tissue temperature information to
determine a specific absorption rate (SAR) around an energy applicator as
a function of the tissue temperature information obtained from the image
data. A possible advantage to taking SAR directly from the patient is
that any tissue inconsistencies in the local area of the antenna or
electrode would be detected using this SAR. Calculating SAR from the
electrode or antenna as it is being used in the patient may allow
detection of the beginning of a non-uniform ablation field.

[0061] In some embodiments, the patient's anatomy may be scanned by one or
more of several scanning modalities, such as CT scanning, MRI scanning,
ultrasound, PET scanning, etc., so as to visualize the tumor and the
surrounding normal tissue. The tumor dimensions may thereby be determined
and/or the location of the tumor relative to critical structures and the
external anatomy may be ascertained. An optimal number and size of energy
applicators might be selected so that the ablation isotherms can
optimally engulf and kill the tumor with a minimal number of electrode
insertions and minimal damage to surrounding healthy tissue.

[0062] Electrosurgical system 100 may include a library 200 including a
plurality of thermal profiles or overlays 202-202n. As it is used in
this description, "library" generally refers to any repository, databank,
database, cache, storage unit and the like. Each of the overlays
202-202n may include a thermal profile that is characteristic of
and/or specific to a particular energy applicator design, particular
energy applicator array, and/or exposure time. Examples of overlay
embodiments are disclosed in commonly assigned U.S. patent application
Ser. No. 11/520,171 filed on Sep. 13, 2006, entitled "PORTABLE THERMALLY
PROFILING PHANTOM AND METHOD OF USING THE SAME", and U.S. patent
application Ser. No. 11/879,061 filed on Jul. 16, 2007, entitled "SYSTEM
AND METHOD FOR THERMALLY PROFILING RADIOFREQUENCY ELECTRODES", the
disclosures of which are incorporated herein by reference in their
entireties.

[0063] Library 200 according to embodiments of the present disclosure may
include a database 284 that is configured to store and retrieve energy
applicator data, e.g., parameters associated with one or energy
applicators (e.g., 1, 2 and 3 shown in FIG. 1) and/or one or more energy
applicator arrays (e.g., "E" shown in FIG. 1). Parameters stored in the
database 284 in connection with an energy applicator, or an energy
applicator array, may include, but are not limited to, energy applicator
(or energy applicator array) identifier, energy applicator (or energy
applicator array) dimensions, a frequency, an ablation length (e.g., in
relation to a radiating section length), an ablation diameter, a temporal
coefficient, a shape metric, and/or a frequency metric. In an embodiment,
ablation pattern topology may be included in the database 284, e.g., a
wireframe model of an energy applicator array (e.g., 25 shown in FIG. 1)
and/or a representation of a radiation pattern associated therewith.

[0064] Library 200 according to embodiments of the present disclosure may
be in communicatively associated with a picture archiving and
communication system (PACS) database (shown generally as 58 in FIG. 1),
e.g., containing DICOM (acronym for Digital Imaging and Communications in
Medicine) formatted medical images. PACS database 58 may be configured to
store and retrieve image data including tissue temperature information.
As shown in FIG. 1, the processor unit 26 may be communicatively
associated with the PACS database 58. In accordance with one or more
presently-disclosed methods, image data associated with a prior treatment
of a target tissue volume may be retrieved from the PACS database 58
and/or received from one or more imaging modalities (e.g., step 2450
shown in FIG. 24), and the SAR is calculated as a function of the tissue
temperature information from the image data (e.g., step 2460 shown in
FIG. 24).

[0065] Images and/or non-graphical data stored in the library 200, and/or
retrievable from the PACS database 58, may be used to configure the
electrosurgical system 100 and/or control operations thereof. For
example, thermal profiling data associated with an energy applicator,
according to embodiments of the present disclosure, may be used as a
feedback tool to control an instrument's and/or clinician's motion, e.g.,
to allow clinicians to avoid ablating critical structures, such as large
vessels, healthy organs or vital membrane barriers.

[0066] Images and/or non-graphical data stored in the library 200, and/or
retrievable from the PACS database 58, may be used to facilitate planning
and effective execution of a procedure, e.g., an ablation procedure.
Thermal profile data associated with an energy applicator, according to
embodiments of the present disclosure, may be used as a predictive
display of how an ablation will occur prior to the process of ablating.
Thermal profile data associated with an energy applicator, according to
embodiments of the present disclosure, may be used to determine a
specific absorption rate (SAR) around the energy applicator. A simulated
radiation pattern for the energy applicator may be generated as a
function of the SAR around the energy applicator. For example, the
Pennes' bio-heat equation coupled with electrical field equations in a
finite element analysis (FEA) environment generally provides a governing
structure for computer simulations modeling energy deposition in
biological tissues. It is envisioned and within the scope of the present
disclosure that the Pennes' bio-heat equation coupled with electrical
field equations in a FEA environment may be used to generate simulated
radiation patterns for an energy applicator as a function of the SAR
around the energy applicator. Images, simulated radiation patterns (e.g.,
"P1" and "P2" shown in FIGS. 20 and 21, respectively) and/or information
displayed on the display device 21 of the user interface 50, for example,
may be used by the clinician to better visualize and understand how to
achieve more optimized results during thermal treatment of tissue, such
as, for example, ablation of tissue, tumors and cancer cells.

[0067] An embodiment of a system (shown generally as 900 in FIG. 9)
suitable for specific absorption rate measurement and characterization of
energy-delivery devices in accordance with the present disclosure
includes the test fixture assembly 300 of FIGS. 2 through 4, a
thermally-sensitive, color-changing medium (e.g., 331 shown in FIGS. 3
and 4) disposed within the test fixture assembly 300, and may include a
hydrogel material 304 disposed around the thermally-sensitive medium.
Test fixture assembly 300 includes a housing 302 including a wall 302a, a
port 303 defined in the wall 302a, and a support member 325 adapted to
support at least a portion of a thermally-sensitive, color-changing
medium disposed within an interior area (shown generally as 301 in FIG.
2) of the housing 302. The thermally-sensitive, color-changing medium may
be a sheet or layer of thermally-sensitive paper or film, may have a
single- or multi-layer structure, and may include a supporting substrate.
A layer of a thermally-sensitive medium may be composed of different
materials.

[0068] Housing 302 may be configured to contain a quantity of a fluid
and/or gel material 304, e.g., an electrically and thermally conductive
polymer, hydrogel, or other suitable transparent or
substantially-transparent medium having electrical and thermal
conductivity. Housing 302 includes a bottom portion 315 and a wall 302a
extending upwardly from the bottom portion 315 to define an interior area
or space (e.g., 301 shown in FIG. 2). Housing 302 may be fabricated from
any suitable material, e.g., plastic or other moldable material, and may
have a substantially rectangular or box-like shape. In embodiments, the
housing 302 may include an electrically non-conductive material, e.g.,
plastics, such as polyethylene, polycarbonate, polyvinyl chloride (PVC),
or the like. Housing 302 may be fabricated from metals, plastics,
ceramics, composites, e.g., plastic-metal or ceramic-metal composites, or
other materials. In some embodiments, the housing 302 is formed of a high
thermal conductivity material, e.g., aluminum. The shape and size of the
housing 302 may be varied from the configuration depicted in FIGS. 2
through 4. Housing 302 may have the different anatomical shapes, such as,
for example, circular, ovular, kidney-shaped, liver-shaped, or lung
shaped, which may allow a clinician to better visualize the potential
effects of thermal treatment on a patient prior to actually performing
the treatment procedure.

[0069] Housing 302, according to embodiments of the present disclosure,
includes one or more ports (e.g., 303 shown in FIG. 3) defined in the
housing 302 and configured to allow at least a distal portion of a probe
(shown generally as 1 in FIGS. 1, 4, 7, 8 and 9) to be disposed in an
interior area of the housing 302. The port(s) may be configured to
accommodate different size probes.

[0070] As shown in FIG. 3, a fixture or fitting 306 may be provided to the
port 303. Fitting 306 may be configured to extend through a wall 302a of
the housing 302. Fitting 306 generally includes a tubular portion (e.g.,
307 shown in FIG. 3) defining a passageway (e.g., 308 shown in FIG. 2)
configured to selectively receive a probe (e.g., 1 shown in FIG. 4)
therethrough. In embodiments, the fitting 306 may be configured to
inhibit leakage of the hydrogel 304 from within the housing 302, e.g.,
when the probe is removed from the fitting 306. Fitting 306 may
additionally, or alternatively, form a substantially fluid tight seal
around the probe when the probe is inserted therethrough. Fitting 306 may
be a single-use fitting. Fitting 306 may be replaceable after each use or
after several uses. Fitting 306 may include, but is not limited to, a
luer-type fitting, a pierceable membrane port, and the like. Guards 306a
may be disposed on opposite sides of the fitting 306 to prevent
inadvertent contact or disruption of the fitting 306. Test fixture
assembly 300, according to embodiments of the present disclosure, may
include a plurality of ports defined in the housing 302, e.g., to
accommodate multiple probes. Test fixture assembly 300 may additionally,
or alternatively, include a plurality of fittings 306.

[0071] In some embodiments, the test fixture assembly 300 includes a
ground ring 310 disposed within the housing 302. Ground ring 310 may
include any suitable electrically-conductive material, e.g., metal such
as aluminum. During operation of the thermal profiling system 900, the
ground ring 310 may receive and/or transmit electromagnetic energy
from/to an energy applicator associated with the test fixture assembly
300. As shown in FIGS. 2 and 3, the ground ring 310 may have a shape that
substantially complements the shape of the housing 302, e.g., to extend
substantially around an inner perimeter of the housing 302. A ground
connection 312 may be provided that is adapted to electrically connect to
the ground ring 310. As shown in FIGS. 3 and 4, the ground connection 312
may extend through a wall of the housing 302, and may be used to
electrically connect the ground ring 310 to an electrosurgical power
generating source (e.g., 16 shown in FIG. 9). In some embodiments, the
ground ring 310 may be removable. The ground ring 310 may be removed in
order to reduce any reflected energy that may be caused by the presence
of the ground ring 310, which may be influenced by probe configuration
and operational parameters. For example, it may be desirable to remove
the ground ring 310 when microwave operational frequencies are used.

[0072] Test fixture assembly 300 according to embodiments of the present
disclosure includes a support member 325 disposed on and extending
inwardly from an inner surface of a wall 302a of the housing 302, and may
include at least one support rod 322 extending upwardly into the housing
302 from a lower surface thereof. FIG. 6 shows an embodiment of the
support member 325 that includes a shelf portion 320, a recess in the
form of a groove 320a defined in the planar top surface "S" of the shelf
portion 320, and a shelf support member 328 coupled to the shelf portion
320. Shelf portion 320 and the shelf support member 328 may be integrally
formed. As shown in FIG. 6, a channel 328a is defined in the shelf
support member 328 and extends therethrough. In some embodiments, the
channel 328a has a substantially cylindrical shape and the groove 320a
has a substantially half-cylindrical shape, and the groove 320a may be
substantially aligned with a lower, half-cylindrical portion of the
channel 328a.

[0073]FIG. 9 shows an embodiment of a thermal profiling system 900
according to the present disclosure that includes the test fixture
assembly 300 of FIGS. 2 through 4 and an imaging system 918. Imaging
system 918 includes an image acquisition unit 912 capable of generating
image data, and may include an image processing unit 954 in communication
with the image acquisition unit 912. Image acquisition unit 912 may
include any suitable device capable of generating input pixel data
representative of an image, e.g., a digital camera or digital video
recorder. An image may have 5120 scan lines, 4096 pixels per scan lines
and eight bits per pixel, for example. As described in more detail
herein, at least one sheet or layer of a suitable thermally-sensitive
medium 331 is disposed within an interior area (shown generally as 301 in
FIG. 2) of the housing 302. Image acquisition unit 912, according to
embodiments to the present disclosure, is configured to capture
time-series image data of thermal radiation patterns formed on the
thermally-sensitive medium 331, and may be disposed over the interior
area of the housing 302 or otherwise suitably positioned to facilitate
image capture of the thermally-sensitive medium 331, or portion thereof.

[0074] In some embodiments, the thermally-sensitive medium 331 may include
liquid crystal (LC) thermometry paper. A plurality of sheets of the
thermally-sensitive medium 331 may be provided to generate a set of
thermal profiles thereon in accordance with characteristics of an energy
applicator and/or parameters and/or settings of a power generating
source. The shape, size and number of sheets of the thermally-sensitive
medium 331 may be varied from the configuration depicted in FIGS. 3 and
4. In some embodiments, the thermally-sensitive medium 331 may have a
shape that conforms to the shape of the selected housing (e.g., 302 shown
in FIGS. 2 through 4) and/or the thermally-sensitive medium 331 may be
shaped to allow circulation of a heated medium, e.g., hydrogel,
thereabout.

[0075] Thermal profiling system 900 may include an electrosurgical power
generating source 16. As shown in FIG. 9, the feedline 1a of the energy
applicator 1 associated with the test fixture assembly 300 may be
electrically coupled to an active port or terminal of the electrosurgical
power generating source 16, and the ground connection 321 of the test
fixture assembly 300 may be electrically coupled to a return port or
terminal of the power generating source 16.

[0076] Thermal profiling system 900, according to embodiments of the
present disclosure, may include a temperature control unit (not shown)
capable of detecting the temperature of the hydrogel 304 and maintaining
the hydrogel 304 at a predetermined temperature or temperature range. In
accordance with embodiments of the present disclosure, the difference
between the ambient temperature of the hydrogel 304 and the threshold
temperature of the thermally-sensitive medium 331 is designed to be
relatively small, e.g., to allow close to adiabatic conditions. For
example, the thermal profiling system 900 may be configured to maintain
the hydrogel 304 at a temperature of about 34.5° C., and the
thermally-sensitive medium 331 may be selected to have a threshold
temperature of about 35.0° C.

[0077] Thermally-sensitive medium 331 according to embodiments of the
present disclosure includes a cut-out portion (e.g., 332 shown in FIG. 5)
defining a void in the thermally-sensitive medium 331. The cut-out
portion may be configured to substantially match the profile of an energy
applicator, and may be configured to provide a gap (e.g., "G" shown in
FIG. 7) between the energy applicator and the thermally-sensitive medium
331 at the edge of the cut-out portion. Thermally-sensitive medium 331
may have any suitable thermal sensitivity. In some embodiments, the
thermally-sensitive medium 331 has a thermal sensitivity of about one
degree Celsius. Thermally-sensitive medium 331, or portion thereof, may
be disposed over at least a portion of the support member 325.
Additionally, or alternatively, at least a portion of the
thermally-sensitive medium 331 may be disposed over one or more support
rods 322.

[0078] In some embodiments, at least a portion of the thermally-sensitive
medium 331 is disposed over the shelf portion 320 and positioned to
substantially align a longitudinal axis (e.g., "A-A" shown in FIG. 5) of
a cut-out portion 332 with a central longitudinal axis (e.g., "A-A" shown
in FIG. 6) of the channel 328a of the shelf support member 328. In some
embodiments, a longitudinal axis (e.g., "A-A" shown in FIG. 5) of the
cut-out portion 332 is arranged parallel to the central longitudinal axis
(e.g., "A-A" shown in FIG. 6) of the channel 328a. As cooperatively shown
in FIGS. 3 and 9, a fitting 306 may be provided to the port 303 defined
in the wall 302a of the housing 302, wherein a tubular portion 307 of the
fitting 306 may be configured to extend through the port 303 and into the
channel 328a of the support member 325. Tubular portion 307 disposed
within the port 303 and channel 328a may help to maintain alignment of
the energy applicator (e.g., 1 shown in FIGS. 4 and 9) with respect to
the cut-out portion 332 of the thermally-sensitive medium 331. Fitting
307 may be provided with a sleeve member (e.g., 308a shown in FIG. 4)
substantially coaxially aligned with the tubular portion 307, e.g., to
provide a resiliently compressible seal around an energy applicator
portion disposed therein. The sleeve member may be formed of a compliant
material, e.g., silicon, natural or synthetic rubber, or other suitable
resiliently compressible material.

[0079] In some embodiments, the shelf portion 320 and one or more support
rods 322 function to support a thermally-sensitive medium 331 within the
housing 302. Shelf portion 320 and the support rod(s) 322, according to
embodiments of the present disclosure, may be configured to support the
thermally-sensitive medium 331 such that the thermally-sensitive medium
331 is maintained in a plane (e.g., "P" shown in FIG. 5) substantially
parallel to a facing surface of the bottom portion 315 of the housing
302. Shelf portion 320 and the support rod(s) 322 may additionally, or
alternatively, be configured to support the thermally-sensitive medium
331 such that the thermally-sensitive medium 331 is maintained in a plane
substantially parallel to a plane of the shelf portion 320. Shelf portion
320 and the support rod(s) 322 may additionally, or alternatively, be
configured to support the thermally-sensitive medium 331 such that a
longitudinal axis (e.g., "A-A" shown in FIG. 5) of the cut-out portion
332 is substantially aligned with the central longitudinal axis (e.g.,
"A-A" shown in FIG. 8) of an energy applicator (e.g., 1 shown in FIG. 8)
associated therewith.

[0080] Thermal profiling system 900, according to embodiments of the
present disclosure, includes a transparent housing portion (e.g., "W"
shown in FIG. 4) for providing viewing into the interior area of the
housing 302, and may include a cover 340 configured to selectively
overlie the housing 302. Cover 340, or portion thereof, may be fabricated
from any suitable transparent or substantially transparent material,
e.g., glass, optically transparent thermoplastics, such as polyacrylic or
polycarbonate. In some embodiments, the housing 302 includes a top edge
portion (e.g., 339 shown in FIG. 2), which can take any suitable shape.
Cover 340 may be releaseably securable to a top edge portion of the
housing 302 by any suitable fastening element, e.g., screws, bolts, pins,
clips, clamps, and hinges.

[0081] As shown in FIG. 9, the thermal profiling system 900 includes an
imaging system 918 operatively associated with the electrosurgical power
generating source 916 and the housing 302, and may include a display
device 21 electrically coupled to the electrosurgical power generating
source 916. For example, the imaging system 918 may include an image
acquisition unit 912 for recording the visual changes occurring in
thermally-sensitive medium 331 and/or parameters and/or settings of the
electrosurgical power generating source 916 (e.g., power settings, time
settings, wave settings, duty-cycle settings, energy applicator 1
configuration, etc.). Imaging system 918 may be communicatively coupled
to a PACS database (e.g., 58 shown in FIG. 1). Imaging system 918 may
also include an image processing unit 954 to which a portable storage
medium 958 may be electrically connected. Portable storage medium 958
may, among other things, allow for transfer of image data in DICOM format
to a PACS database (e.g., 58 shown in FIG. 1). As shown in FIG. 9, the
image processing unit 954 is electrically connected between the image
acquisition unit 912 and the power generating source 916, and may be
electrically connected to the display device 21.

[0082] Hereinafter, a method of measuring specific absorption rate and
characterizing an energy applicator using a thermal phantom and image
analysis in accordance with the present disclosure is described with
reference to FIGS, 1 through 9. Test fixture assembly 300 of FIGS. 2
through 4 is provided, and a hydrogel material 304 is introduced into the
interior area 301 of the housing 302 of the test fixture assembly 300. A
thermally-sensitive medium 331 including a cut-out portion 332 is placed
into the housing 302 containing hydrogel 304 therein, e.g., in such a
manner that a color changing side of the thermally-sensitive medium 331
is facing the cover 340 or away from the bottom portion 315.
Thermally-sensitive medium 331 may be positioned within the housing 302
such that at least a portion of thermally-sensitive medium 331 is placed
on the shelf portion 320 of the support member 325 and/or at least a
portion of thermally-sensitive medium 331 is placed on support rods 322.
In one embodiment, fasteners, such as screws, may be used to secure the
thermally-sensitive medium 331 to the shelf portion 320 and/or the
support rods 322. With the thermally-sensitive medium 331 submerged in
hydrogel 304 within the housing 302, the cover 340 may be secured to the
housing 302, e.g., to substantially enclose the thermally-sensitive
medium 331 within the housing 302.

[0083] The selected energy applicator (e.g., 1 shown in FIGS. 1, 4 and 9)
is introduced into the housing 302 through the port 303 by placing a
distal tip portion (e.g., 1b shown in FIG. 1) into a fitting 306 disposed
therein and advancing the energy applicator therethrough until at least a
portion of the radiating section of the energy applicator is located with
the cut-out portion 332 of the thermally-sensitive medium 331. As shown
in FIG. 7, the energy applicator 1 disposed in the cut-out portion 332
may be spaced apart a distance or gap "G" from the thermally-sensitive
medium 331. Gap "G" may be configured to be as narrow a distance as can
be achieved, without making contact between the thermally-sensitive
medium 331 and the energy applicator 1. In some embodiments, the gap "G"
may be about 1 millimeter. As shown in FIG. 7, the width of the gap "G"
may be substantially the same around the entire periphery of the energy
applicator 1, e.g., to minimize errors in the image processing and
analysis stage.

[0084] Energy applicator 1 is electrically connected to an active port or
terminal of electrosurgical power generating source 916, and the ground
connection 312 of the test fixture assembly 300 is electrically connected
to a return port or terminal of power generating source 916. Test fixture
assembly 300, according to embodiments of the present disclosure, is
adapted to maintain the position of at least a distal portion of the
energy applicator 1 disposed within the test fixture assembly 300 such
that the central longitudinal axis (e.g., "A-A" shown in FIG. 8) of the
energy applicator I is substantially parallel to a plane (e.g., "P" shown
in FIG. 5) containing the thermally-sensitive medium 331.

[0085] In some embodiments, the power generating source 916 is configured
or set to a predetermined setting. For example, power generating source
916 may be set to a predetermined temperature, such as a temperature that
may be used for the treatment of pain (e.g., about 42° C. or about
80° C.), a predetermined waveform, a predetermined duty cycle, a
predetermined time period or duration of activation, etc.

[0086] When the energy applicator 1 is positioned within the test fixture
assembly 300, the imaging system 918 may be activated to record any
visual changes in the thermally-sensitive medium 331, the settings and/or
parameters of the power generating source 916, and the configuration of
the energy applicator 1.

[0087] According to an embodiment of the present disclosure, prior to
activation of the electrosurgical power generating source 916, a
temperature of the hydrogel 304 within the housing 302 is stabilized to a
temperature of approximately 37° C. When the power generating
source 916 is activated, electromagnetic energy communicated between the
radiating section (e.g., "R1" shown in FIG. 4) of the energy applicator 1
and ground ring 310 affects the thermally-sensitive medium 331 to create
a thermal image (e.g., "S1" shown in FIG. 10) thereon.

[0088] The method may further include operating the imaging system 918 to
capture a time series of thermal images (e.g., "S1", "S2" and "S3" shown
in FIGS. 10, 12 and 14, respectively). For example, the temperature
gradients or "halos" created on the thermally-sensitive medium 331 may be
captured by the image acquisition unit 912 of the imaging system 918, and
may be stored electronically in the image processing unit 954 or the
portable storage medium 958 communicatively coupled thereto. As heat
generated by the electromagnetic radiation emitted from energy applicator
1 affects the thermally-sensitive medium 331, the temperature gradients
or "halos", e.g., colored rings or bands, indicate areas of relatively
higher temperature and areas of relatively lower temperature. It is
contemplated that the particular thermally-sensitive medium 331 used may
be selected so as to display only a single temperature of interest as
opposed to a range of temperatures.

[0089] Additionally, the imaging system 918 may record and store the
settings and/or parameters of the electrosurgical power generating source
916 (e.g., temperature, impedance, power, current, voltage, mode of
operation, duration of application of electromagnetic energy, etc.)
associated with the creation of the image on the thermally-sensitive
medium 331.

[0090] Following the acquisition of images created on the
thermally-sensitive medium 331, the power generating source 916 may be
deactivated and the energy applicator 1 withdrawn from the housing 302.
The used thermally-sensitive medium 331 may be removed from the housing
302 and replaced with a new or un-used thermally-sensitive medium 331.
The above-described method may be repeated for the same or different set
of settings and/or parameters for the power generating source 916 and/or
the same or different energy applicator 1 configuration.

[0091] Thermal profiling system 900 may be used in conjunction with any
suitable hypothermic and/or ablative energy system including, for
example, microwave energy systems employing microwave antennas for
delivering ablative energy. The above-described thermal profiling system
900 has been specifically described in relation to the characterization
of a single energy applicator 1. However, it is envisioned and within the
scope of the present disclosure that test fixture assembly 300 be
configured to receive multiple energy applicators, e.g., two or more, and
for images and/or data to be acquired thereof, in accordance with the
method described above.

[0092] During use of the thermal profiling system 900, the image
acquisition unit 912 of the imaging system 918 acquires a series of
images of the thermally-sensitive medium 331 with color bands formed
thereon disposed around the energy applicator 1. Image acquisition unit
912 may acquire a series of images with varying time delays before image
acquisition. In some embodiments, the image acquisition unit 912 acquires
a time series of images wherein the series of images is recorded along
time at uniform time intervals.

[0093] FIGS. 10, 12 and 14 show an energy applicator 1 disposed within the
cut-out portion 332 of the thermally-sensitive medium 331 with
schematically-illustrated representations of thermal radiation patterns
"S1", "S2" and "S3" respectively, formed on the
thermally-sensitive medium 331 during use of the thermal profiling system
900 at time t equal to t1, t2 and t3, respectively. In
FIGS. 10, 12 and 14, a plurality of color bands (also referred to herein
as temperature bands) are shown around the energy applicator 1. The
shape, size and number of temperature bands on the thermally-sensitive
medium 331 may be varied from the configurations depicted in FIGS. 10, 12
and 14.

[0094] Imaging system 918, according to various embodiments, includes an
image processing unit 954 in communication with the image acquisition
unit 912. A time series of image data acquired by the image acquisition
unit 912 (or image data from other imaging modalities such as MRI) may be
inputted and stored in a memory (not shown) of the image processing unit
954. According to embodiments of the present disclosure, one or more
temperature bands (e.g., "B1", "B2", "B3" and/or "B4"
shown in FIG. 14) may be selected, either manually by the user, e.g.,
using a pointing device (e.g., 27 shown in FIG. 1) and/or the touchscreen
capability of a display device (e.g., 21 shown in FIG. 1), or
automatically, e.g., by the image processing unit 954, for image
processing to generate data for use in characterizing the energy
applicator 1.

[0095] A method according to embodiments of the present disclosure
includes thresholding to segment an image data by setting all pixels
whose intensity values are above a predetermined threshold to a
foreground value and all the remaining pixels to a background value.

[0096] FIGS. 11, 13 and 15 show thresholded pattern images "T1",
"T2" and "T3", respectively, of a portion of the
thermally-sensitive medium of FIGS. 10, 12 and 14 showing a selected
temperature band "B2" at time t equal to t1, t2 and
t3, respectively.

[0097] A method according to embodiments of the present disclosure
includes generating image data on the basis of thresholded pattern images
of the selected temperature band (e.g., "B" shown in FIGS. 16A and 17A)
surrounded by an inner boundary (e.g., "IB" shown in FIGS. 16B and 17B)
and/or an outer boundary (e.g., "OB" shown in FIGS. 16B and 17B).

[0098] FIG. 16A shows a selected temperature band "B" at time t equal to
tn, and FIG. 17B shows the temperature band "B" at time t equal to
tn+1. As illustratively shown in FIGS. 16B and 17B, thresholding of
time-series image data may be used to detect an inner boundary and an
outer boundary of the selected color band in each image data of the
time-series image data.

[0099] An example of the positional relationships between two points lying
on the boundaries of a temperature band (e.g., "B" of FIGS. 16B and 17B)
is shown in FIGS. 18 and 19. For illustrative purposes, the inner and
outer boundaries "L1" and "L2", respectively, of a temperature band, at
time t equal to tn (shown by the solid curved lines in FIG. 18 and
the dashed curved lines in FIG. 19), and at time t equal to 61 (shown by
the solid curved lines in FIG. 19), are plotted on a coordinate grid
having equal scale units "D". In the interest of simplicity, unit "D" may
be taken to be equal to the width of the cut-out portion, for
illustrative purposes. It is contemplated that other spatial data or
features may be used to establish a measurement scale, such as grid lines
or marks, or objects, placed on the thermally-sensitive medium prior to
image acquisition, or the diameter of the energy applicator.

[0100] In FIGS. 18 and 19, each of the points "P1" and "P2" may
correspond to a single pixel or to a group of pixels. Referring to FIG.
18, at time t equal to tn, the point "P1" on the inner boundary
"L1" is spaced apart a length "J" from an edge point of the cut-out
portion, and the point "P2" on the outer boundary "L2" is spaced
apart a length "K" from an edge point of the cut-out portion. In this
example, the length "J" is equal to 2 times the unit "D". Turning now to
FIG. 19, at time t equal to tn+1, the point "P1" on the inner
boundary "L1" is spaced apart a length "L" from a cut-out portion edge
point, and the point "P2" on the outer boundary "L2" is spaced apart
a length "M" from a cut-out portion edge point. In this example, the
length "L" is equal to 2.5 times the unit "D". In the present example, it
can be calculated from the coordinate grid that, from a time t equal to
tn to t equal to tn+1, the point "P1" on the inner
boundary "L1" of the temperature band moves, from a first position to a
second position on the coordinate grid, a distance equal to one-half of
the unit "D". According to an embodiment of the present disclosure,
determination of the positional change of point "P1" on the inner
boundary "L1" of the temperature band provides the value of the
temperature difference, ΔT, for use in calculating the specific
absorption rate. The difference in time from a time t equal to tn to
t equal to tn+1 may be set by the frame rate of the image
acquisition device (e.g., 912 shown in FIG. 9).

[0101] The specific absorption rate (SAR) may be calculated by the
following equation:

S A R = c ρ Δ T Δ
t , ( 4 ) ##EQU00004##

where c.sub.ρ is the specific heat of the hydrogel 304 (in units of
Joules/kg-° C.), ΔT is the temperature difference (°
C.), and Δt is the time period in accordance with the frame rate,
or a fraction or multiple thereof, in seconds.

[0102] Hereinafter, methods of directing energy to tissue are described
with reference to FIGS. 22 and 24. It is to be understood that the steps
of the methods provided herein may be performed in combination and in a
different order than presented herein without departing from the scope of
the disclosure.

[0103] FIG. 22 is a flowchart illustrating a method of directing energy to
tissue according to an embodiment of the present disclosure. In step
2210, an energy applicator (e.g., "E" shown in FIG. 1) is positioned for
delivery of energy to tissue (e.g., "T" shown in FIG. 1), wherein the
energy applicator is operably associated with an electrosurgical power
generating source (e.g., 16 shown in FIG. 1).

[0104] In step 2220, one or more operating parameters associated with the
electrosurgical power generating source is determined based on specific
absorption rate data associated with the energy applicator. Examples of
operating parameters associated with the electrosurgical power generating
source include without limitation temperature, impedance, power, current,
voltage, mode of operation, and duration of application of
electromagnetic energy. According to embodiments of the present
disclosure, the specific absorption rate data associated with the energy
applicator is based on one or more temperature bands selected from
time-series image data associated with the energy applicator. In some
embodiments, the specific absorption rate data associated with the energy
applicator may be based on positional transition of at least one boundary
of the selected temperature band of the time-series image data. As
described in detail below, FIG. 23 is a flowchart illustrating a sequence
of method steps for performing the step 2320 according to an embodiment
of the present disclosure.

[0105] In step 2230, energy from the electrosurgical power generating
source is transmitted through the energy applicator to tissue. In some
embodiments, the electrosurgical power generating source is a microwave
energy source, and may be configured to provide microwave energy at an
operational frequency from about 300 MHz to about 10 GHz.

[0106]FIG. 23 is a flowchart illustrating a sequence of method steps for
performing the step 2220 of determining one or more operating parameters
associated with the electrosurgical power generating source based on
specific absorption rate data associated with the energy applicator. In
step 2221, time-series image data (e.g., "S1", "S2" and
"S3" shown in FIGS. 10, 12 and 14, respectively) associated with an
energy applicator (e.g., 1 shown in FIGS. 4 and 9) is acquired.

[0107] In step 2222, a color band (e.g., "B2" shown in FIGS. 10, 12
and 14) of the time-series image data is selected. Selecting the color
band of the time-series image data, in step 2222, may include outputting
one or more image data of the time-series image data to a display device.
A pointing device may be provided to enable user selection of the color
band. According to embodiments of the present disclosure, one or more
temperature bands (e.g., "B1", "B2", "B3" and/or "B4"
shown in FIG. 14) may be selected, either manually by the user, e.g.,
using a pointing device (e.g., 27 shown in FIG. 1) and/or the touchscreen
capability of a display device (e.g., 21 shown in FIG. 1), or
automatically, e.g., by an image processing unit (e.g., 954 shown in FIG.
9).

[0108] In step 2223, the time-series image data is thresholded (e.g.,
"T1", "T2" and "T3" shown in FIGS. 11, 13 and 15,
respectively) to detect an inner boundary (e.g., "IB" shown in FIGS. 16B
and 17B) and/or an outer boundary (e.g., "OB" shown in FIGS. 16B and 17B)
of the selected color band in each image data of the thresholded
time-series image data. Thresholding the time-series image data, in step
2223, may include setting all pixels whose intensity values are above a
predetermined threshold to a foreground value and all the remaining
pixels to a background value.

[0109] In step 2224, a change in temperature is determined as a function
of positional transition (e.g., "P1" from "J" to "L" shown in FIGS.
18 and 19) of the inner boundary (e.g., "L1" shown in FIGS. 18 and 19)
and/or the outer boundary (e.g., "L2" shown in FIGS. 18 and 19) of the
selected color band in each image data of the thresholded time-series
image data.

[0110] In step 2225, a specific absorption rate around the energy
applicator is calculated as a function of the determined change in
temperature. Calculating the specific absorption rate, in step 2225, may
include obtaining a frame rate of an image acquisition device associated
with the time-series image data. The specific absorption rate calculation
may be performed using equation (4), as discussed hereinabove.

[0111]FIG. 24 is a flowchart illustrating a method of directing energy to
tissue according to an embodiment of the present disclosure. In step
2410, an energy applicator (e.g., "E" shown in FIG. 1) is positioned for
delivery of energy to a target tissue volume (e.g., "T" shown in FIG. 1).
The energy applicator may be inserted directly into tissue, inserted
through a lumen, e.g., a vein, needle or catheter, placed into the body
during surgery by a clinician, or positioned in the body by other
suitable methods. The energy applicator is operably associated with an
electrosurgical power generating source (e.g., 16 shown in FIG. 1).

[0112] In step 2420, one or more operating parameters associated with the
electrosurgical power generating source is determined based on specific
absorption rate data associated with the energy applicator. Step 2420 is
similar to the step 2220 shown in FIG. 22, and further description
thereof is omitted in the interests of brevity.

[0113] In step 2430, energy from the electrosurgical power generating
source is transmitted through the energy applicator to the target tissue
volume.

[0114] In step 2440, image data including tissue temperature information
of the target tissue volume is acquired by imaging the target tissue
volume using one or more imaging modalities. The tissue temperature
information acquired by the one or more imaging modalities may be
determined by any suitable method, e.g., calculated from density changes
within the tissue.

[0115] In step 2450, image data is received from the one or more imaging
modalities. For example, image data representative of one or more images
may be communicated between a medical imaging system (e.g., 30 shown in
FIG. 1) and a processor unit (e.g., 26 shown in FIG. 1) via wired
communication and/or wireless communication.

[0116] In step 2460, the specific absorption rate (SAR) is calculated as a
function of the tissue temperature information from the image data. A
possible advantage to taking SAR directly from the patient is that any
tissue inconsistencies in the local area of the antenna or electrode
would be detected using this SAR. Calculating SAR from the electrode or
antenna as it is being used in the patient may allow detection of the
beginning of a non-uniform ablation field.

[0117] The SAR calculation may be performed using equation (2), where c is
the specific heat of the tissue (in units of Joules/kg-° C.), At
is the time interval (in seconds), and ΔT is the temperature rise
(in ° C.) within the time interval Δt. Equation (2) is
restated below.

Δ T = 1 c S A R Δ
t , ( 2 ) ##EQU00005##

which can be rewritten as follows:

S A R = c Δ T Δ t .
##EQU00006##

[0118] In embodiments, in response to early detection of a potentially
anomalous condition, e.g., detection of the beginning of a non-uniform
ablation field, or under other circumstances, one or more operating
parameters associated with an electrosurgical power generating source
(e.g., operably associated with the electrode or antenna) may be
determined based on the SAR, in step 2470. Some examples of operating
parameters associated with an electrosurgical power generating source
that may be determined include temperature, impedance, power, current,
voltage, mode of operation, and duration of application of
electromagnetic energy.

[0119] In embodiments, the position of the energy applicator may be
adjusted based on the calculated specific absorption rate. For example,
an energy applicator with a directional radiation pattern may be rotated
either manually, or automatically, based on the calculated specific
absorption rate, e.g., to avoid ablating sensitive structures, such as
large vessels, healthy organs or vital membrane barriers. Examples of
antenna assemblies rotatable such that any elongated radiation lobes
rotates therewith are disclosed in commonly assigned U.S. patent
application Ser. No. 12/197,405 filed on Aug. 25, 2008, entitled
"MICROWAVE ANTENNA ASSEMBLY HAVING A DIELECTRIC BODY PORTION WITH RADIAL
PARTITIONS OF DIELECTRIC MATERIAL", U.S. patent application Ser. No.
12/535,856 filed on Aug. 5, 2009, entitled "DIRECTIVE WINDOW ABLATION
ANTENNA WITH DIELECTRIC LOADING", and U.S. patent application Ser. No.
12/476,960 filed on Jun. 2, 2009, entitled "ELECTROSURGICAL DEVICES WITH
DIRECTIONAL RADIATION PATTERN", the disclosures of which are incorporated
herein by reference in their entireties.

[0120] The above-described systems and methods may involve the use of data
associated with image analysis of a thermal phantom for calculation of
SAR (e.g., used to predict a radiation pattern emitted by an energy
applicator) to facilitate planning and effective execution of a
procedure, e.g., an ablation procedure.

[0121] The above-described systems and methods may involve the use of
image data including tissue temperature information to calculate SAR as a
function of the tissue temperature information during a procedure (e.g.,
used to determine one or more operating parameters associated with an
electrosurgical power generating source). As described above, image data
including tissue temperature information (e.g., acquired by one or more
imaging modalities) may be stored in DICOM format in a PACS database, and
the stored image data may be retrieved from the PACS database prior to
and/or during a procedure, e.g., for use in calculating SAR during the
procedure. As described above, image data including tissue temperature
information may be received from one or more imaging modalities during a
procedure, e.g., for use in calculating SAR during the procedure. One or
more operating parameters associated with an electrosurgical power
generating source may be determined using real-time (or near real-time)
tissue temperature data acquired from one or more imaging modalities
during the procedure, e.g., an ablation procedure.

[0122] According to various embodiments of the present disclosure, the SAR
around an energy application, as determined by the above-described
methods, may be used to predict a radiation pattern emitted by an energy
applicator, and/or control the positioning of an electrosurgical device
(e.g., rotation of a energy applicator with a directional radiation
pattern to avoid ablating sensitive structures, such as large vessels,
healthy organs or vital membrane barriers), and/or control an
electrosurgical power generating source operatively associated with an
energy applicator.

[0123] Although embodiments have been described in detail with reference
to the accompanying drawings for the purpose of illustration and
description, it is to be understood that the inventive processes and
apparatus are not to be construed as limited thereby. It will be apparent
to those of ordinary skill in the art that various modifications to the
foregoing embodiments may be made without departing from the scope of the
disclosure.